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NCT02407405 · ClinicalTrials.gov registry record · Phase 2
MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas
A Phase 2 study of Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (PN), sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02407405 is a Phase 2 study of Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (PN) that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02407405, a Phase 2 study of Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (PN), is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Neurofibromatosis type 1 (NF1) is a disorder that can cause plexiform neurofibromas (PNs). These are tumors that grow along nerves. Some PNs cause serious health problems. PNs often can t be operated on because of their large size, location, or number. There are no effective treatments known for people with NF1 and PNs. Researchers want to test if the drug selumetinib (AZD6244 hydrogen sulfate) causes PNs to shrink or slows down their growth. Objectives: To test if selumetinib helps treat PNs. To test how the body handles selumetinib and how it affects peoples symptoms. Eligibility: People ages 18 and older with NF1, with an inoperable PN that causes morbidity or is growing Design: Participants will be screened with: Medical history and physical exam Blood, urine, and heart tests Eye exam MRI: They lie in a machine that takes pictures of the body. PN biopsy: A small piece of the tumor is removed by a large needle. Questionnaires Participants will swallow selumetinib capsules every 12 hours for several 28-day cycles. The capsules are taken with a full glass of water on an empty stomach. Participants may have only water for 2 hours before and 1 hour after each dose. Participants will keep a drug diary. They will continue taking the drug as long as they tolerate it and their disease doesn t progress. Participants will have several visits throughout the study. These will include repeats of the screening tests. Participants will have a final visit after they stop taking selumetinib.
Conditions Studied
Interventions
- DRUG Selumetinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2030-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02407405
The ClinicalTrials.gov registry entry for NCT02407405 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neurofibromatosis 1 (NF1) appearing as the primary indexed condition, and to 1 intervention - of which Selumetinib is the first listed.
NCT02407405 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02407405 about?
NCT02407405 is a clinical study titled "MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas". Background: Neurofibromatosis type 1 (NF1) is a disorder that can cause plexiform neurofibromas (PNs). These are tumors that grow along nerves. Some PNs cause serious health problems. PNs often can t be operated on because of their large size, location, or number. There are no effective treatments ...
What is the current status of trial NCT02407405?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2016-01-07. Estimated completion is 2030-01-01.
What conditions does trial NCT02407405 study?
This clinical trial studies the following conditions: Neurofibromatosis 1 (NF1), Plexiform Neurofibromas (PN).
What interventions are being tested in trial NCT02407405?
The interventions under investigation include: Selumetinib (DRUG).
Who is sponsoring clinical trial NCT02407405?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02407405 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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